MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	G10678
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other healthcare professional.Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, a (b)(6) female patient was undergoing a hemodialysis arteriovenous graft maintenance procedure using a performer introducer.Another manufacturer's 12x4 balloon was being used through the complaint sheath.Upon removal of the balloon from the complaint device, there was noticeable leaking from the sheath valve.Blood loss was minimal with no medical intervention required.The complaint device was replaced with another performer introducer to successfully complete the procedure.There was no patient adverse effect.The complaint device will not be returned to the manufacturer to aid in the investigation.Reason unknown.
Additional Manufacturer Narrative
Investigation ¿ evaluation a review of the complaint history, device history record, manufacturing instructions, instructions for use (ifu), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8583118
• Report Number: 1820334-2019-01126
• Device Sequence Number: 2348923
• Product Code: DYB
• UDI-Device Identifier: 00827002106789
• UDI-Public: (01)00827002106789(17)211101(10)9279406
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: G10678
• Device Catalogue Number: RYCFW-7.0-35-6-RB-CW
• Device Lot Number: 9279406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 102